What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.
In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our Guru Edge. She has more than 15 years of experience in Medical Devices and has worked in a variety of quality and regulatory roles.
Listen to the episode to learn what Maryann has to share about the cultural barriers between engineering and quality management, the challenges she experienced as a compliance manager, and what aspects of implementing an eQMS stood out.
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Some of the highlights of this episode include:
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What the compliance manager role was like for Maryann and what it meant to her
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The relationship with compliance across departments
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Auditing across sites
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Pains companies go through when looking for quality management systems
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Cultural barriers between engineering and quality control
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Compliance manager challenges
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How the quality management system is like a design project
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The contrast in quality manager vs. compliance matter
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Implementing an eQMS and the difference between that and a paper system
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The relationship between compliance and quality departments
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Advice for people filling multiple roles
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Advice for companies working toward compliance and developing a quality mindset.
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Memorable quotes from Maryann Mitchell:
“Engineers love to iterate, they love to tinker, but you need to be able to document something, and that’s the importance of it so you can go back to it if you need to.”
“We built better processes going forward so we wouldn’t recreate this problem.’
“I love that you get to defend your quality system.”
“A quality system doesn’t work in a silo, and what I was seeing was departments working in silos.”
About the Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
